FDA panel recommends approval for Boehringer Ingelheim COPD drug

RIDGEFIELD, Conn. — A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.

BI announced that the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of the drug olodaterol, which the company plans to market under the name Striverdi Respimat. The drug is a once-daily bronchodilator treatment for airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. The FDA is not required to follow advisory committee decisions when deciding whether or not to approve a drug, but usually does.

"We at Boehringer Ingelheim are pleased with the advisory committee’s recommendation and look forward to continuing to work with the FDA as the agency continues its review of the olodaterol [new drug application]," BI Pharmaceuticals VP clinical development and medical affairs for respiratory Tunde Otulana said. "The positive vote from the advisory committee marks an important step toward making olodaterol available to the approximately 24 million patients with COPD in the United States."

FDA approves Genzyme drug for rare cholesterol disorder

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating a rare cholesterol disorder, the agency said.

The FDA announced the approval of Kynamro (mipomersen sodium), made by Genzyme for the treatment of homozygous familial hypercholesterolemia, or HoFH. Kynamro has been approved as an orphan drug, a designation the FDA gives to drugs that treat diseases affecting fewer than 200,000 people.

The disease is an inherited condition affecting about one-in-1 million people in the United States and prevents the body from removing low-density lipoprotein cholesterol from the bloodstream. For people with HoFH, heart attacks and death often occur before age 30.

"Kynamro, an injection given once a week, works with other lipid-lowering medications and diet to impair the creation of the lipid particles that ultimately give rise to LDL-C," FDA Division of Metabolism and Endocrinology Products deputy director Eric Colman said.

The FDA approved another drug for HoFH, Aegerion Pharmaceuticals’ Juxtapid (lomitapide), in December 2012.

Eli Lilly reports 1% Q4 decline from Zyprexa patent expiration

INDIANAPOLIS — Eli Lilly and Company on Tuesday reported that its fourth quarter revenue for the period ended Dec. 31 declined 1% to $6 billion because of its Zyprexa patent expiration. Full-year 2012 revenue declined 7% to $22.6 billion.

"Lilly delivered solid financial results in the fourth quarter of 2012, as we successfully offset a large part of the revenue decline from the Zyprexa patent expiration with growth in other products such as Cymbalta, Forteo, Alimta, Effient and our animal health portfolio," stated John Lechleiter, Lilly’s chairman, president and CEO. "At the same time, we continued to control costs while investing in R&D in order to replenish and advance our pipeline. Today, Lilly has 13 potential new medicines in Phase III testing. We are well-positioned to deliver on our innovation-based strategy and create long-term value for all of our stakeholders."

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